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Digital therapeutics (DTx) for Empowering Patients

Digital Therapeutics: Empowering Patients to Take Charge of Chronic Conditions 

All Category, Blogs, regulatory /

Chronic conditions such as diabetes, hypertension, COPD, and depression account for over 70% of global healthcare costs and are the leading cause of disability-adjusted life years (DALYs) worldwide (WHO, 2024). Traditional care pathways, while effective, often rely on episodic clinician interactions, leaving gaps in ongoing patient engagement, self-management, and behavior modification.    Digital Therapeutics (DTx) […]

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How Pharmacogenomics Is Powering Personalized Medicine

Your Genes, Your Treatment Plan: How Pharmacogenomics Is Powering Personalized Medicine

All Category, Blogs, Clinical Regulatory, regulatory /

A patient walks into a clinic. Two people have the same diagnosis, yet their treatments are completely different. One responds quickly. The other experiences side effects. The difference? Their genes.    Welcome to the world of pharmacogenomics, where your genetic blueprint guides your treatment plan. This isn’t a glimpse of future medicine, it’s already reshaping

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Regulatory expertise for medical device approval in India

Achieve Faster Medical Device Approval in India with Regulatory Expertise

All Category, Blogs, regulatory /

India’s medical device market is one of the fastest growing in the world, According to Invest India, India’s medical device market valued at around USD 11 billion in 2022–23, is projected to reach USD 50 billion by 2030, growing at a CAGR of approximately 16.4% [Report]. As global manufacturers and startups set their sights on this high-potential market, regulatory

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Insights on Regulatory Requirements for QPPV and Deputy QPPV in Saudi Arabia

Regulatory Insight for QPPV and Deputy QPPV Appointments in Saudi Arabia 

All Category, Blogs, Pharmacovigilance /

In the global pharmaceutical market, ensuring drug safety through proper pharmacovigilance practices is paramount. Regulatory agencies around the world mandate robust systems to monitor, assess, and report adverse drug reactions (ADRs) in a timely manner. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) plays a crucial role in overseeing the safety of pharmaceutical

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mexico cosmetic product registration process according to cofepris guidelines

COFEPRIS Cosmetics Registration Process: Guide for Global Brands Entering Mexico 

All Category, Blogs, regulatory /

As the Mexican cosmetics market continues to expand, attracting attention from global beauty brands, understanding local regulatory requirements becomes essential for successful market entry. Navigating the complexities of Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the country’s regulatory authority overseeing health and safety, is critical for ensuring that your products meet local

COFEPRIS Cosmetics Registration Process: Guide for Global Brands Entering Mexico  Read More »

generative ai transforming life sciences drug discovery and development

Exploring the Future of Generative AI in Life Sciences

All Category, Blogs, regulatory /

Generative Artificial Intelligence (Gen AI) has become a buzzword in the tech world, but its application goes far beyond creating content like text, images, and videos. While these creative applications are exciting, the real power of generative AI lies in its ability to generate entirely new data, models, and scientific insights transforming fields like life

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Generic drug registration and Approval process in Taiwan

Taiwan Generic Drug Registration Process

All Category, Blogs, regulatory /

As global pharmaceutical companies intensify their focus on Asia-Pacific markets, Taiwan has emerged as a key strategic hub offering a stable regulatory environment, robust IP protection, and a high generic drug uptake under a universal healthcare system. Despite its relatively modest population, Taiwan punches above its weight in terms of healthcare spending and quality standards. 

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PV Requirements for medical devices and combination products

Global Pharmacovigilance Requirements for Devices and Combination Products

All Category, Blogs, Medical Device, Pharmacovigilance /

The traditional boundaries separating pharmaceuticals, biologics, and medical devices have blurred. With the rise of combination products, from drug-eluting stents and prefilled autoinjectors to inhalers with embedded sensors, the regulatory landscape has undergone a seismic shift. While pharmacovigilance (PV) for pharmaceuticals is well-established, the safety monitoring of PV for devices and combination products introduces distinct technical and

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SAHPRA CTM lifecycle in South Africa

Navigating SAHPRA: A Guide for Complementary and Traditional Health Products in South Africa

All Category, Blogs, regulatory /

Complementary and traditional health products are now subject to increasing regulatory oversight in South Africa, driven by SAHPRA’s evolving mandate. Once considered outside the formal regulatory scope, CTMs are now under increasing scrutiny by the South African Health Products Regulatory Authority (SAHPRA). This shift signals the government’s intent to ensure that all health-related products regardless

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ost-market evidence generation for long-term healthcare access in PV and HTA

Post-Market Evidence Generation: Bridging PV and HTA for Long-Term Access

All Category, Blogs, Pharmacovigilance /

Post-market evidence generation is becoming a strategic priority for life sciences companies. After a drug or medical device gains regulatory approval, the focus quickly shifts to long-term access, pricing, and continued patient benefit. This shift requires new, real-world evidence to validate both product safety and health system value.  At the intersection of pharmacovigilance (PV) and

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